Metabolomic and Inflammatory Effects of Oral Aspirin (ASA) in Subjects at Risk for Melanoma

Melanoma (Skin) Clinical Trial

Official title:

Pilot Studies Assessing the Metabolomic and Inflammatory Effects of Oral Aspirin (ASA) in Human Subjects at Risk for Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04062032
• Other study ID #: HCI94424 Pilot
• Status: Completed
• Phase: Phase 2
• Start date: September 27, 2016
• Est. completion date: February 27, 2019

Study information

• Verified date: February 2022
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open label phase II pilot study assessing the metabolomic and inflammatory effects of oral aspirin (ASA) in human subjects at risk for melanoma.

Description:

Primary Objectives

I. Open label trial in 60 patients to assess the capacity of either of one daily dose (81, 325 mg) of sub-chronic ASA administration to increase the plasma and nevus ASA metabolites such as: salicylate, salicylurate, gentisic acid, and salicyl acyl glucuronide.

II. Open label trial in 60 patients to assess the capacity of sub-chronic daily ASA (81, 325 mg) administration to reduce levels of prostaglandin E2 (PGE2) in plasma and nevi.

Secondary Objectives

I. Determine whether ASA increases AMP-activated protein kinase (AMPK) activation in nevi.

II. Determine whether ASA affects whole blood leukocytes or leukocyte subsets in plasma.

III. Determine whether ASA affects inflammatory cytokines in plasma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: February 27, 2019
• Est. primary completion date: February 27, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must have at least 2 nevi (each >5 mm diameter) not clinically suspicious for melanoma that can be biopsied.

• Must be older than age 18.

• Must be able to receive informed consent and sign an approved consent form that conforms to federal and institutional guidelines.

Exclusion Criteria:

• The patient is a minor, under age 18.

• The patient cannot speak / understand English or Spanish.

• The patient is pregnant or breastfeeding.

• The patient is a prisoner, critically or mentally ill, or otherwise incapacitated or considered vulnerable.

• The patient has history of allergic reaction to ASA.

• The patient has history of severe asthma.

• The patient has been taking ASA or any NSAID in the past 2 weeks.

• The patient has been taking a blood thinner in the past 2 weeks.

• The patient has history of bleeding disorder.

• The patient has history of peptic ulcer disease.

• The patient has had recent intense UV exposure in the past month.

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Drug:
• Aspirin 81 mg
ASA 81mg taken daily
• Aspirin 325mg
ASA 325mg taken daily

Locations

Country	Name	City	State
United States	Huntsman Cancer Institute/University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in concentration of ASA metabolites (salicylate and salicylurate) in plasma after ASA ingestion	Concentration (ng/mL) of pre-treatment ASA metabolites (salicylate and salicylurate) in plasma will be compared to the concentration of ASA metabolites at day 7	Change from baseline to day 7
Primary	Change in concentration of ASA metabolites in nevus tissue after ASA ingestion	Pre-treatment ASA metabolites in tissue will be compared to ASA metabolites at day 7	Change from baseline to day 7
Primary	Change in concentration of prostaglandin E2 (PGE2) in plasma after ASA ingestion	Baseline PGE2 levels in plasma specimens will be compared to PGE2 levels at day 7.	Change from baseline to day 7
Primary	Change in concentration of prostaglandin E2 (PGE2) in nevus tissue after ASA ingestion	Baseline PGE2 levels in tissue specimens will be compared to PGE2 levels at day 7.	Change from baseline to day 7
Secondary	Change in AMP-activated protein kinase (AMPK) activation in nevi after ASA ingestion	Quantitative densitometry analysis using Western blots will be performed on tissue collected at baseline and at day 7 to compare activation of AMP-activated protein kinase (AMPK).	Change from baseline to day 7
Secondary	Change in concentration of leukocytes in peripheral blood after ASA ingestion	Whole blood will be taken at baseline and at day 7 to compare concentration of leukocytes	Change from baseline to day 7